The reliably pro-business subsidy editors of the Wall Street Journal ask an important question—will the members of Joe Biden’s COVID-19 task force support fast-tracking the Pfizer and Moderna vaccines?
Some critics of the Trump FDA’s accelerated approvals are on Mr. Biden’s Covid task force. Take Ezekiel Emanuel, who helped inspire ObamaCare’s bureaucratic panel for cutting Medicare spending, which Congress has since repealed. He believes government needs to clamp down on doctors who prescribe treatments that incrementally help patients, especially the elderly with fewer years to live.
Then there’s David Kessler, the FDA commissioner in the George H.W. Bush and Clinton Administrations. Mr. Kessler let the agency be hijacked by trial lawyers and banned most silicone breast implants because of unascertainable risks, which many women said they were willing to bear. During his tenure, approvals of new medical devices ground to a halt.
One of the big jobs of “the FDA commissioner is to put their body on the line in between all the forces that want to influence the agency,†Mr. Kessler told Politico in August. What he meant is the agency should ignore doctors and patients who want access to therapies that don’t pass this “expert†bureaucratic obstacle course.
Perhaps I’m the dog in the manger here but I think a healthy skepticism should be applied to both Pfizer and Moderna’s vaccine for a simple reason: to the best of my knowledge we have no experience at all with its modality of operation. Has any treatment or therapy using “messenger RNA” (mRNA) been in use for any substantial period of time?
I think I understand the urgency with which many including the editors view the situation but I would urge caution. There are so many things we just don’t know. Do treatments involving mRNA have side effects, particularly side effects which take considerable time to emerge, of which we are presently completely unaware? Yogi Berra’s advice is relevant: in theory there’s no difference between theory and practice but in practice there is. How long will the protection last? What are the effects of repeated inoculations, not just twice as required by the vaccines but possibly many times?
Another factor to take into account: even with fast-tracked approval and multiple vendors it will take years to inoculate enough people to make a substantial difference. If we were to limit inoculation just to the U. S. and it had widespread acceptance it would still take a couple of years. We’re talking about inoculating 7.5 billion people and we can’t even get everybody to inoculate their kids against measles. After the smallpox vaccine was invented it took 184 years before smallpox was eradicated. It’s been nearly 70 years since the polio vaccine was invented and polio is still not eradicated. Dealing with COVID-19 will be a marathon not a sprint.
And another concern is liability. If the FDA fast-tracks it and something goes wrong down the road, who is on the hook when the lawsuits come in? I’m guessing the pharma companies will want some kind of protection from that if the normal protocols are going to be skipped or shortened. That’s typically not something Democrats support.
Emergency authorizations of vaccine are allowed under the Federal Food, Drug and Cosmetics Act for emergencies. Various tests and treatments have already been given emergency use authorizations, so I don’t think there is any question that this is an emergency. The FDA published regulatory guidance in Spring on how it would handle emergency use authorizations for vaccines and it appears that that Pfizer and Modella are plan to request one shortly.
Presumably the FDA will take a few weeks to review and approve them. It should be quicker, these tests appear to have far exceeded the efficacy levels needed for approval. No significant problems were identified in Phase I and II, which were where safety issues predominate before vaccinating tens of thousands of people. And assuming its an emergency, we’re pretty much talking about comparing risks of the vaccine vs. the risks of not having a vaccine. We have a virus that is killing thousands of people in the U.S. every week, and a vaccine that has killed nobody.
@andy, federal law mostly bars lawsuits against vaccine manufacturers and directs claims to one of two compensation programs that are funded by a tax on vaccines. Some people have rare adverse reactions to standard vaccines, but typically as I recall it being discussed with the thimerosal claims that were rejected, it is fairly immediate.
Congress already passed the National Childhood Vaccine Injury Act (NCVIA) which deals with possible liability due to a vaccine.
I don’t know whether the act covers vaccines with an EUA approval. It would be wise for Congress to address this specific question.
As I wrote in the post, I understand the sense of urgency. But I think we’re comparing apples and oranges. To date 3% of the population has been confirmed to have contracted COVID-19 and of those about 2% have died or, said another way, .06% of the population has died. The testing has involved about 20,000 people IIRC.
We’re talking about inoculating 100% of the population, two orders of magnitude greater than who have been confirmed to have contracted the disease and four orders of magnitude greater than those who have received the vaccines to date. That is an enormous difference and it would be completely flabbergasting if no additional adverse reactions were to be seen. And that doesn’t even address the longitudinal points I’ve made.
Again, I recognize the sense of urgency. I’m not scoffing at it. But we’re not talking about smallpox or Ebola and a little more concern about safety would seem warranted to me.
It should be noted that RNA technology as therapeutic is not experimental. There have been approved drugs using RNA to treat other diseases since 2016 (?). It is the use of RNA technology for the purpose of a vaccine that is new (through it has been in the research pipeline for a couple of decades now).
We don’t need 100% of the population vaccinated. If the reproduction number (R0) is between 2.5 and 3.5, then herd immunity kicks in at about 60% to 72% of the population. If the vaccines are 90% effective then approximately 66% to 80% of the population needs to be vaccinated.
That simple model does not take into consideration heterogeneities, which lower practical herd immunity to somewhere btw/ 20% and 60%. Places that were hit hard like NYC (a sample of 22% recently found to have Covid-19 antibodies) appear to be saturated and are not experiencing the wave hitting other places. Whether or not its herd immunity, it would be great if 20% of the people in my city were immunized, particularly if they targeted workers at long-term care facilities, prisons, etc.
60% X 330 million = 198,000,000 people. That’s 4 orders of magnitude larger than the number participating in the testing.
PD- I think your basic reasoning is correct, nd I love the word heterogeneities, but we have seen many predictions about when we will see herd immunity. We just dont know as it is a new virus. Not the kind of thing I want to make plans around. What I do think is that we can keep the R value below 1 with even moderately low levels of vaccinations if it is 90% effective. (Assuming sterilizing effect.)
Steve
Assuming the vaccine is 90% effective regardless of age / comorbidity. Actually the key is vaccinating those at highest risk ( > 50 years, with comorbidity). That’s a substantial but less than 50% of the population. That’s roughly 120 million people.
If those at highest risk of needing hospital care are vaccinated , then the threat of health care system overload is eliminated and the disruption to life decreases substantially.
And I repeat: to the best of my knowledge no drug using messenger RNA has been licensed for use in human beings on other than an experimental basis so, yes, it is an experimental strategy. Not just in vaccines.